Cleared Traditional

MICROLITE MICROTITER PLATE LUMINOMETER ML2200

K920888 · Dynatech Laboratories, Inc. · Chemistry
Mar 1992
Decision
37d
Days
Class 1
Risk

About This 510(k) Submission

K920888 is an FDA 510(k) clearance for the MICROLITE MICROTITER PLATE LUMINOMETER ML2200, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on March 19, 1992, 37 days after receiving the submission on February 11, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.

Submission Details

510(k) Number K920888 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1992
Decision Date March 19, 1992
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KHO — Fluorometer, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2560

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